Samsung Bioepis Secures FDA approval for Stelara biosimilar

The FDA has approved PYZCHIVA to be a biosimilar of Stelara, according to Samsung Bioepis. Its biosimilarity to Stelara is confirmed by extensive information, which forms the basis of the approval.

This covers non-clinical, analytical, and research findings that do not demonstrate appreciable variations in terms of potency, purity, or safety.

In healthy participants, a Phase I clinical investigation showed that PYZCHIVA and Stelara had similar immunogenicity characteristics, protection, and pharmacokinetic equivalency. The biosimilarity of SB17 to Stelara was further substantiated by clinical findings from a Phase III study comprising individuals with mild to serious plaque psoriasis.

Samsung Bioepis vice-president and regulatory affairs team leader Byoung In Jung commented: “The FDA approval of PYZCHIVA as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments.

They continued: “In addition, biosimilars have a potential to reduce the financial burden of healthcare systems, especially in the US where biologics account for more than 46% of the annual drug spending.”